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Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

2011年4月1日 更新者：Wyeth is now a wholly owned subsidiary of Pfizer

An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B

This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

35

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100730
        • Pfizer Investigational Site
      • Shanghai、中国、200025
        • Pfizer Investigational Site
    • Guangzhou
      • Guangzhou、Guangzhou、中国、510515
        • Pfizer Investigational Site
    • Jiangsu
      • Suzhou、Jiangsu、中国、215006
        • Pfizer Investigational Site
    • Tianjin
      • Tianjin、Tianjin、中国、300020
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • Pfizer Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)
  • Subjects with previous exposure to FIX replacement therapy
  • If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion Criteria:

  • Diagnosed with any bleeding disorder in addition to hemophilia B
  • Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory)
  • Subject has no history of exposure to FIX products (previously untreated patient [PUP])
  • Subject is currently utilizing primary FIX prophylaxis
  • Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
  • Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
  • Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
  • Subjects with a known hypersensitivity to hamster protein
  • Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN)
  • Prothrombin Time >1.5 x ULN
  • Platelet count <80,000/µL
  • Pregnant or breastfeeding women
  • Unwilling or unable to follow the terms of the protocol
  • Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Benefix
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
生物：Benefix
BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion
大体时间：8 hours post infusion
Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.
8 hours post infusion
Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion
大体时间：24 hours post infusion
Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.
24 hours post infusion
Percentage of Participants With FIX Inhibitor Development
大体时间：Baseline up to 6 months
Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
Baseline up to 6 months

次要结果测量

结果测量
措施说明
大体时间
Number of Infusions Required to Treat Each Bleed
大体时间：Baseline up to 6 months
The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.
Baseline up to 6 months
FIX Incremental Recovery
大体时间：Baseline (Visit 2) up to 6 months (Visit 4)
FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.
Baseline (Visit 2) up to 6 months (Visit 4)
Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)
大体时间：Baseline up to 6 months
The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.
Baseline up to 6 months
Percentage of Participants With Allergic-Type Allergic Reactions
大体时间：Baseline up to 6 months
Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.
Baseline up to 6 months
Percentage of Participants With Thrombosis
大体时间：Baseline up to 6 months
Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.
Baseline up to 6 months
Percentage of Participants With Red Blood Cell (RBC) Agglutination
大体时间：Baseline up to 6 months
RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.
Baseline up to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Wyeth is now a wholly owned subsidiary of Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年2月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2009年3月19日

首先提交符合 QC 标准的

2009年3月19日

首次发布 (估计)

2009年3月20日

研究记录更新

最后更新发布 (估计)

2011年4月5日

上次提交的符合 QC 标准的更新

2011年4月1日

最后验证

2011年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3090A1-3305
  • B1821004

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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医疗条件

药物干预

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条件

罕见疾病

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